Bioequivalence of Two Mixtard® 30 Formulations in Healthy Subjects
Phase 1
Completed
- Conditions
- DiabetesHealthy
- Interventions
- Drug: biphasic human insulin 30
- Registration Number
- NCT01486888
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Europe. The aim of this trial is to to test for bioequivalence between two formulations of Mixtard® 30 in healthy subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria
- Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
- Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2, inclusive
- Non-smoker, defined as no nicotine consumption for at least one year
- Fasting plasma glucose below or equal to 100 mg/dL (5.6 mmol/L)
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Exclusion Criteria
- Previous participation in this trial or other clinical trials within the last 3 months
- Body weight above 87.5 kg
- Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (IUD) that has been in place for at least 3
- History of alcohol or drug abuse
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Formulation B biphasic human insulin 30 - Formulation A biphasic human insulin 30 -
- Primary Outcome Measures
Name Time Method Maximum serum insulin concentration (Cmax) Area under the serum insulin concentration-time curve (AUC 0-24 hours)
- Secondary Outcome Measures
Name Time Method Area under the serum insulin concentration-time curve (AUC 6-24 hours) Area under the serum insulin concentration-time curve (AUC 0-6 hours) Terminal insulin half life (t½) Area under the serum insulin concentration-time curve (AUC 0-inifinity hours) Time to maximum serum insulin concentration (tmax) Adverse events